The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients. This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Topical hydrogel plaster (700mg lidocaine)
Topical hydrogel plaster
Site 31
Abbeville, France
Site 26
Bayonne, France
Site 34
Bobigny, France
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain
Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).
Time frame: daily assessments over 4 weeks
Effect of lidocaine 5% medicated plaster on quality of life
EuroQol-5 Dimension Scores
Time frame: 4 weeks
Neuropathic Pain Symptoms
Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations
Time frame: 4 weeks
Incidence of adverse events
Measurement of adverse events including those derived from laboratory data or vital signs measurements.
Time frame: up to 44 days
Hospital Anxiety and Depression Scale
Time frame: 4 weeks
Subject's Global Impression of Change
Time frame: 4 weeks
Treatment Satisfaction Questionnaire for Medication
Time frame: 4 weeks
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Site 35
Bordeaux, France
Site 12
Boulogne-Billancourt, France
Site 24
Brest, France
Site 15
Châteauroux, France
Site 30
Corbeil-Essonnes, France
Site 39
La Roche-sur-Yon, France
Site 23
Lille, France
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